MEDTECH ACQUISIT(MTAC) - 2024 Q1 - Quarterly Report

Financial Performance - TriSalus Life Sciences, Inc. reported a revenue of $3.1 million from the sale of 350,000 shares of common stock under the SEPA during the three months ended March 31, 2024[143]. - Revenue for the three months ended March 31, 2024, increased by$3.5 million or 116.4% compared to the same period in 2023, primarily due to higher units of TriNav sold[165]. - Cost of goods sold rose by $0.3 million or 46.7$3.2 million or 136.3%, with gross margin improving to 85.0% from 77.8% due to enhanced manufacturing efficiencies[167]. - The company incurred a net loss of $13.2 million for the three months ended March 31, 2024, compared to a net loss of$8.3 million in the same period of 2023[176]. - Net cash used in operating activities was $10.9 million for the three months ended March 31, 2024, compared to$10.5 million in the same period of 2023[180]. Research and Development - The company anticipates submitting a New Drug Approval (NDA) request for nelitolimod to the FDA no sooner than 2025, with potential commercial sales beginning in 2027[139]. - TriSalus is currently in Phase 1 human trials for nelitolimod, which aims to treat hepatocellular cancer and pancreatic cancer[145]. - The company expects R&D expenses to increase significantly as it advances nelitolimod through clinical development[155]. - Research and development expenses increased by $0.2 million or 3.8$3.4 million or 105.8%, attributed to increased payroll and travel expenses for sales personnel[170]. - The company expects to incur significant expenses related to TriNav, including sales and marketing expenses and production capacity expansion to support anticipated sales growth[187]. Financing and Capital Requirements - The company raised $3.6 million from the sale of 400,000 shares of common stock under the SEPA in April 2024[143]. - The company expects to require substantial additional funding to support ongoing operations and development efforts, particularly for its lead product candidate nelitolimod[184]. - Future capital requirements will depend on the success of TriNav's commercialization, including patient and physician adoption and reimbursement adequacy[187]. - The company plans to finance cash needs through securities offerings, debt financings, collaborations, and licensing arrangements, which may dilute existing ownership interests[188]. - The company has lease obligations totaling$1.6 million as of March 31, 2024, reflecting minimum commitments for administrative and production facilities[193]. - As of March 31, 2024, the company has paid Dynavax $12 million and may owe up to an additional$158 million upon achieving certain development and regulatory milestones for nelitolimod[194]. - The company may also need to pay up to $80 million upon achieving certain commercial milestones once sales of nelitolimod begin[194]. Credit and Debt - TriSalus has a Credit Agreement providing for up to$50.0 million in senior secured term debt, with an initial commitment amount of $25.0 million borrowed on April 30, 2024[145][146]. - The company is subject to affirmative and restrictive covenants under the Credit Agreement, limiting its ability to incur additional debt or make capital expenditures[188]. Operational Changes - The company has terminated arrangements with distributors for product sales in geographic markets where it does not have a sales presence as of December 31, 2022[150]. - There have been no significant changes in critical accounting policies during the three months ended March 31, 2024, compared to the previous year[196]. Going Concern - There is substantial doubt regarding the company's ability to continue as a going concern as of March 31, 2024[192]. - The company has no off-balance sheet financing arrangements or relationships with unconsolidated entities[195]. Regulatory and Compliance - The TriNav Infusion System received a permanent New Technology HCPCS code effective January 1, 2024, which may enhance reimbursement opportunities[138].